The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Specified dose on specified days.
Local Institution - 0002
Beijing, Beijing Municipality, China
Annualized relapse rate (ARR) over 36 months
Time frame: Up to 3 years
Annualized relapse rate (ARR) over 12 months and 24 months
Time frame: Up to 2 years
The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36
Time frame: Up to 3 years
The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36
Time frame: Up to 3 years
Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36
Time frame: Up to 3 years
Proportion of participants who are GdE lesion-free at Months 12, 24, and 36
Time frame: Up to 3 years
Proportion of participants with adverse events (AEs)
Time frame: Up to 40 months
Proportion of participants with serious adverse events (SAEs)
Time frame: Up to 40 months
Proportion of participants with AEs leading to discontinuation of study treatment
Time frame: Up to 3 years
Proportion of participants with laboratory abnormalities
Time frame: Up to 40 months
Proportion of participants with vital sign abnormalities
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Local Institution - 0012
Guangzhou, Guangdong, China
Local Institution - 0022
Guangzhou, Guangdong, China
Local Institution - 0008
Shenzhen, Guangdong, China
Local Institution - 0004
Shijiazhuang, Hebei, China
Local Institution - 0006
Harbin, Heilongjiang, China
Local Institution - 0018
Zhengzhou, Henan, China
Local Institution - 0007
Wuhan, Hubei, China
Local Institution - 0003
Nanchang, Jiangxi, China
Local Institution - 0005
Changchun, Jilin, China
...and 15 more locations
Time frame: Up to 40 months
Proportion of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 40 months
Proportion of participants with physical examination abnormalities
Time frame: Up to 40 months
Proportion of participants with serious or opportunistic infections
Time frame: Up to 40 months
Proportion of participants with malignancy
Time frame: Up to 40 months
Proportion of participants with bradycardia and heart condition abnormalities
Time frame: Up to 40 months
Proportion of participants with pulmonary toxicity
Time frame: Up to 40 months
Proportion of participants with macular edema
Time frame: Up to 40 months
Proportion of participants with hepatotoxicity
Time frame: Up to 40 months
Proportion of participants with posterior reversible encephalopathy syndrome
Time frame: Up to 40 months
Proportion of participants with progressive multifocal leukoencephalopathy
Time frame: Up to 40 months